FORMULATION AND EVALUATION OF TIMOLOL MALEATE OCULAR IN SITU GEL
Sukhram Rathore, Trapti Shrivastava, Prithu Pathak, Kuldeep Ganju
ABSTRACT
The present study was aimed at the formulation and evaluation of an ocular in situ gel of timolol maleate for the effective management of glaucoma. The objective was to enhance ocular residence time and provide sustained drug release while improving patient compliance. In situ gel formulations (F1–F9) were prepared using sodium alginate as a gelling agent. The formulations were evaluated for clarity, pH, drug content, in situ gelling capacity, viscosity, in vitro drug release, release kinetics, and stability. Clarity studies revealed that formulations F1–F8 were clear, whereas F9 showed turbidity. Drug content of all formulations ranged between 96.72% and 99.28%, indicating uniform drug distribution. The pH of all formulations was adjusted to 5.0 ± 0.1 to ensure ocular compatibility. Formulations F4, F5, and F6 exhibited immediate gelation with prolonged gel integrity. Viscosity studies showed low viscosity before administration and a significant increase after gelation, ensuring ease of instillation and prolonged ocular residence. The optimized formulation F5 demonstrated sustained drug release with 98.60% cumulative drug release over 5 hours and followed first-order release kinetics (R² = 0.9800). Stability studies confirmed that formulation F5 remained stable over 30 days with no significant changes in drug content or gelling capacity. The study concludes that the developed timolol maleate ocular in situ gel is a promising system for sustained glaucoma therapy.
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